Post-Intensive Care Syndrome - Pediatrics (PICS-p): Longitudinal Cohort Study

NCT ID: NCT04967365

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 755 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2026-06-30

Brief Summary

Pediatric Intensive Care Unit (PICU) survival has increased substantially over the past three decades. Currently, an understanding of PICU morbidity and recovery among PICU survivors and their families is limited. Post-intensive care syndrome (PICS) consists of new or worsening impairments in physical, cognitive, or mental health status that arise and may persist after critical illness. The characteristics of PICS in children (PICS-p) are unknown. The objective of this study is to learn about pediatric recovery from critical illness to guide future intervention research to optimize child and family health.

Detailed Description

PICS-p is a prospective longitudinal cohort study of pediatric patients experiencing 3 or more days of intensive care therapies at one of approximately 30 U.S. PICUs to evaluate child and family outcomes over two years post-PICU discharge. We will compare outcomes of these PICU patients with a control group of patients who received an overnight PICU stay but did not receive intensive care therapies, as well as with published quality of life data from the general and chronically ill populations. Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff, and their post-discharge outcomes will be followed centrally from the University of Pennsylvania and the Seattle Children's Research Institute. Our specific aims are to determine the physical, cognitive, emotional, and social health outcomes and trajectory of recovery in a population of children post-critical illness; to determine the baseline health, presenting problem, and PICU factors associated with impaired physical, cognitive, emotional, and social outcomes among PICU survivors; and to determine the emotional and social health outcomes in parents and siblings of PICU survivors. Our primary goal is to explicate the impact of pediatric critical illness over a two-year period of time to guide future intervention research to optimize child and family outcomes. Our overall goal is to improve the health and well-being of PICU survivors and their families.

Conditions

Critical Illness; Post Intensive Care Unit Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Case patients

500 patients who experience greater than or equal to 3 nights in a pediatric ICU with intensive care instrumentation.

No interventions assigned to this group

Control patients

250 patients who experience an overnight stay in a pediatric ICU without intensive care instrumentation.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Current admission is the child's first PICU (including pediatric subspecialty ICU) admission

2. Patient age ≥4 weeks and ≥44 weeks corrected gestational age and <16 years (has not yet reached 16th birthday) on PICU admission

3. At least one parent/legal guardian (≥18 years of age or considered emancipated) living with the potential subject

4. PICU LOS of 3 days (covering at least 3 nights from midnight to 7am) in which the patient received intensive care therapies for organ dysfunction (for example, invasive mechanical ventilation, vasopressors/inotropes, acute renal replacement therapy, or other extracorporeal therapies).

5. Anticipated patient discharge to home (directly or indirectly after a stay in another facility)

Exclusion Criteria

1. Patient history of neonatal intensive care unit hospitalization

2. Life expectancy not anticipated to be more than one year (e.g., active do not resuscitate [DNR] plan or actively managed by the palliative care team for end-of-life symptom management)

3. Patient in foster care or ward of the state

Control subjects: As above but will be PICU patients who received an overnight PICU stay (<36 hours covering one midnight to 7am time period) that did not include intensive care therapies. Post-operative children who were intubated/extubated in the operating room/PACU (or intubated in the operating room and extubated in the PICU on arrival and prior to parent presence at the bedside) can be enrolled as control subjects. Control subjects will be frequency matched to cases on age group, sex, and medical complexity, that is, complex chronic disease (C-CD), noncomplex chronic disease (NC-CD), and without CD on a 2:1 case:control ratio.

Family Subjects: At least one eligible parent/legal guardian must be willing to participate. In addition, up to two cognitively capable siblings (PCPC of 1 or 2) aged 8 to <16 years, who live with the patient, and who have not been ICU hospitalized will be invited to participate. If more than two siblings are eligible, the two siblings with the next birthday (regardless of birth year) will be invited to participate.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martha AQ Curley, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

R. Scott Watson, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Alabama Children's Hospital

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Annopinder Bhalla MD

Los Angeles, California, United States

Lucille Packard Children's Hospital Stanford

Palo Alto, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Children's Hospital of Atlanta

Atlanta, Georgia, United States

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Comer Children's Hospital

Chicago, Illinois, United States

Riley Children's Health at Indiana University

Indianapolis, Indiana, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Charlotte R Bloomberg Children's Center

Baltimore, Maryland, United States

CS Mott Children's Hospital

Detroit, Michigan, United States

Massonic Children's Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

St Louis Children's Hospital

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

UNC Children's Hospital Chapel Hill

Chapel Hill, North Carolina, United States

Brenner Children's Hospital

Winston-Salem, North Carolina, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Doernbecher Children's Hospital

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

LeBonheur Children's Hospital

Memphis, Tennessee, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Children's Hospital of Richmond

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

Curley MAQ, Watson RS, Killien EY, Kalvas LB, Perry-Eaddy MA, Cassidy AM, Miller EB, Talukder M, Manning JC, Pinto NP, Rennick JE, Colville G, Asaro LA, Wypij D. Design and rationale of the Post-Intensive Care Syndrome - paediatrics (PICS-p) Longitudinal Cohort Study. BMJ Open. 2024 Feb 24;14(2):e084445. doi: 10.1136/bmjopen-2024-084445.

Reference Type: DERIVED

PMID: 38401903 (View on PubMed)

Other Identifiers

843844

Identifier Type: -

Identifier Source: org_study_id